Advancing your drug to regulatory approval in the most efficient and cost-effective manner requires a concentrated effort every step of the way. The right data demands the right people with the right knowledge in the right parts of the world.
Led by scientific and technical experts, the RAM Software Solutions Inc Biometrics team has the clinical data management and statistical expertise to consistently deliver high-quality data that accelerates your clinical development process. Involved at every phase of drug development – from study design to delivery of the Integrated Clinical Statistical Report – our highly-qualified team of specialized statisticians, programmers, and medical writers have a better understanding of data supporting our therapeutic areas of expertise.
Our global standard operating procedures (SOPs), combined with continuous quality control, ensure consistent, efficient, and comprehensive data that meet all Sponsor protocol requirements.
Delivering high quality data management, superior statistics, and expert report writing, we are responsive, flexible, and knowledgeable in our approach so you can have complete confidence in your data for the entire duration of drug development. We undertake each study with one goal in mind – correctly preparing your statistical data for submission, on time and on budget.
Data Management – Our data management partner team provides high-quality collection, organization, validation, analysis, and quality control of clinical trial data and utilizes electronic data capture (EDC) to expedite data collection.
Led by a team of experts which includes former FDA government officials, with broad experience and insight in pre- and post-marketing drug regulation, the RAM Software Solutions Inc Regulatory Affairs Department provides comprehensive international support to Sponsors at all stages of the drug development process.
With a long track record of regulatory submissions around the globe, we are well-versed in all aspects of the clinical trial submission process, to both IRBs/ethics committees and to FDA and ex-US competent authorities. Up-to-date in the evolving regulatory requirements by region, every RAM Software Solutions Inc project team is fully-engaged from progRAM initiation to reporting of results across phases I-IV of drug development. Highly qualified medical writers, regulatory staff, data managers, and statisticians work in concert with your team to ensure the clinical, scientific, and regulatory integrity of every project – from pre-IND/IND/IMPD submission through marketing application submission and regulatory review.
RAM Software Solutions Inc has developed and maintains Electronic Common Technical Document (eCTD) capabilities for full NDA filings, which have been validated by the FDA in both mock and actual application submissions. Our dedicated experts are focused on producing the most meaningful, comprehensive, and submission-ready compilation of your non-clinical and clinical data and manufacturing information – ensuring compliance with FDA and other regulatory agency requirements and guaranteeing every phase of trial is correctly focused for optimum results.Services include
The Regulatory Affairs Department compiles all components of your Investigational New Drug (IND) applications, including nonclinical and clinical summaries, investigator brochures and updates. Leveraging our insight into the specific areas of drug approval and our successful track record of communication with the FDA, we expedite your original IND submission to accelerate the drug development process. Our highly qualified medical writers and regulatory staff apply the principles of good scientific and medical writing when preparing your IND documents, facilitating approval of applications to conduct clinical trials of new drugs.Our IND associated goals and responsibilities typically include:
Safety and pharmacovigilance risk management has gained increased importance in global drug development due to a number of recent high profile drug withdrawals and growing expectations from consumers regarding product safety. While RAM Software Solutions Inc is focused on rapid approval of your compound, we also recognize the importance of identifying and assessing risk during clinical trials. To meet increasingly complex and diverse global regulatory requirements, RAM Software Solutions Inc has developed a comprehensive suite of services designed to ensure safety and expedite approvals. This process is monitored by licensed physicians who are trained to provide appropriate oversight and to analyze and evaluate the emerging safety profile of your compoundServices provided by RAM Software Solutions Inc Safety and Pharmacovigilance include:
We offer services for the development, implementation, deployment and maintenance of enterprise financial systems. Our experience designing, implementing and customizing applications for security trading, portfolio management, risk management, asset securitization, e-Finance and Financial operations will give your firm the ability to deliver quality integrated financial systems while providing the ability to closely manage the resource investment for their delivery. In addition, we offer several packaged products that can be combined with our consulting and integration services to improve your edge in the market and improve your delivery time.Service Offerings: You can leverage our services and our experience with the entire development process to help with some or all aspects of the delivery of your Finance project:
RAM Software Solutions Inc Medical Writing team provides professional writing services and quality reviews to the pharmaceutical, biotechnology, and medical device industries via individual subject matter experts or full delivery teams, working either onsite or offsite to support medical writing activities. More..